An Integration of Tai Chi and rTMS for Physical and Psychological Well-being in Older Adults With Sleep Disturbance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Insomnia Severity
研究概览
简要总结
This is a novel and the first study to investigate the impacts of the integrated treatment of Tai Chi (TC) and repetitive transcranial magnetic stimulation (rTMS) on sleep disturbances and the potential mechanisms of arousal system. To validate the combination of TC and rTMS as a promising approach for managing sleep disturbance in older adults, the investigators will conduct a four-arm, parallel-group, randomized controlled trial comprising a 4-week treatment phase and a 3-month follow up period. A total of 152 eligible participants will be recruited and randomly assign to the TC plus active rTMS (38 participants), TC plus sham rTMS (38 participants), TC-alone (38 participants), and low-intensity PE (38 participants) control group within two weeks after the baseline assessment. TC plus active rTMS, TC plus sham rTMS, and TC-alone will be compared with a low-intensity PE control group on insomnia severity, various sleep parameters assessed by self-report sleep diary and ActiGraph, emotional states, and physical and mental health related quality of life. The investigators have formulated two hypotheses in this study. First, the three intervention groups, relative to participants undergoing PE, will confer greater improvement in all measured outcomes at post-intervention (T1) and three-month follow-up (T2); and second, in the double-blinded groups, the TC plus active rTMS will show greater improvement in all measured outcomes than TC plus sham rTMS at T1 and T2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age of at least 60 years
- •Active sleep disturbance as indicated by the Pittsburgh Sleep Quality Index (PSQI) score exceeding 5 and the Insomnia Severity Index (ISI) score greater than 7 at screening
- •No prior experience of mind-body exercises (i.e., TC, Qigong, or yoga, etc.) and regular moderate-intensity exercise (i.e., above three times per week and 30 minutes per session) in the past 6 months
- •Provide written informed consent
排除标准
- •Cognitive impairment as determined by the Montreal Cognitive Assessment scored less than 22
- •Major confounding conditions known to induce sleep perturbations, such as psychiatric disorders or chronic pain disorder
- •History of head injury or epilepsy, intracranial implant, cardiac pacemaker, or any other contraindication to rTMS
- •Obvious physical disability that precluded participant in the interventions
结局指标
主要结局
Insomnia Severity
时间窗: at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up)
Measured by Insomnia Severity Index, it's a 7-item questionnaire assessing insomnia severity over the past two weeks. Items scored 0 to 4 and total score range is from 0 to 28. Total score of 7 or less indicate no clinically significant insomnia, 8 to 14 indicate subthreshold insomnia, and 15 or greater indicate moderate to severe insomnia.
次要结局
- Actigraphy-assessed sleep parameters(at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up))
- Self-reported sleep parameters(at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up))
- Daytime sleepiness(at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up))
- Cortical arousal(at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up))
- Emotional states(at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up))
- Mental function and physical function(at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up))
- Somatic arousal and cognitive arousal(at Week 0 (baseline), Week 4 (posttreatment), and Week 16 (follow-up))
研究者
TSANG Hector Wing-Hong
Proferssor
The Hong Kong Polytechnic University